ARLINGTON, Va. President Barack Obama’s budget proposal, which includes an approval pathway for biosimilars, won praise from the Generic Pharmaceutical Association last week.

“For patients across the country suffering from cancer, diabetes and other diseases, the support stated by president Obama today for a workable biogenerics approval pathway is lifesaving news,” GPhA president and CEO Kathleen Jaeger said in a statement. “With countless patients struggling to pay the high costs of brand biopharmaceuticals, an approval pathway for safe, effective and affordable biogeneric medicines that provides access sooner rather than later is desperately needed.”

The model that the Hatch-Waxman Act of 1984 established for generic drugs provides a five-year period of data exclusivity for branded pharmaceutical drugs, which GPhA favors for biosimilars as well. However, the Biotechnology Industry Organization favors a 14-year data exclusivity period, saying that the Hatch-Waxman model would not provide sufficient time for biotech companies to recoup research and development expenses, thus stifling innovation.

Advanced Vision Research launches new OTC supplement for AMD

WOBURN, Mass. Advanced Vision Research has launched an OTC vitamin supplement for macular degeneration and diabetic retinopathy, the eye disease treatment company announced Thursday.

MacuTrition Eye Vitamin and Mineral Supplement contains fish oil omega-3 fatty acids, vitamin D and green tea extract for age-related macular degeneration and diabetic eye disease. AMD has no cure and is the leading cause of blindless in Americans older than 65. In addition, 5 million of the23 million Americans with diabetes have diabetic retinopathy and macular edema, and 97% of insulin-dependent diabetics will develop retinopathy.

“By targeting oxidation, inflammation and angiogenesis, we take a multi-pronged approach to maintaining eye health, especially in those with diabetes and macular degeneration, including those at risk, i.e. family members,” Advanced Vision Research CEO Jeffrey Gilbard stated.

GLENDALE, Calif. IntraVera Worldwide will be launching its BruiseMD product at the 2009 Natural Products Expo West, the company announced. BruiseMD will be available in tablets, cream, gel and as an analgesic balm.

The oral version of BruiseMD features natural plant extracts, including pineapple and papaya. The topical versions feature Arnica Montana, a natural ingredient used to heal bruises in combination with topical analgesics for pain relief.

“Every day, nearly 350,000 Americans suffer a new bruise,” stated Raymond Ealy, president and CEO. “There is a pressing consumer need for a product that specifically treats bruises.”

“BruiseMD will speed up the healing process of all three types of bruises: subcutaneous bruises, or those beneath the skin; intramuscular bruises, those within the underlying muscle; and periosteal, or bone bruises, the most severe and painful,” reported James Caillouette, co-founder and board member of IntraVera Worldwide. “Until now, doctors and pharmacists could only recommend the use of pain relievers to treat bruises. These products can decrease bruise pain, but do nothing to heal the bruise.”

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Coming toward the end of the calendar year, there will be many consumers perusing purchases of over-the-counter medicines and devices in an effort to deplete their flexible spending accounts, many of which still contain a “use-it-or-lose-it” provision.

Private label just keeps chugging along.
Thanks to strong consumer demand for lower-priced alternatives to national brands and retailer desires to differentiate themselves from the competition, private label seems to keep gaining more traction in the retail world.

In a Journal of Advanced Nursing study of 90 adults with type 2 diabetes published last week, female gender, elevated blood sugar levels, neuropathic pain, and fatigue were related to sleep disturbance, even after controlling for factors such as age, diabetes duration, depressive symptoms and distress.

Ascensia Diabetes Care, based out of Basel, Switzerland, is showing its support for World Diabetes Day 2017 by publishing 30 portraits of inspiring women who are making significant contributions to advancing diabetes care.

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